Under the EU Medical Device Regulation (MDR), manufacturers are required to plan, conduct, and document a clinical evaluation in accordance with Article 61, part A of Annex XI. This evaluation must be based on clinical data providing sufficient clinical evidence to demonstrate: Despite being among the highest risk, certain implantable and Class III devices may...
For implantable and Class III devices, the requirement to conduct a clinical investigation as part of the CE marking process has not changed compared to the EU Medical Device Directive (MDD). However, whereas the MDD included minimal requirements regarding such clinical investigation, the EU Medical Device Regulation (MDR) provides detailed legal requirements for conducting a...
As a sponsor wisely noted, “Clinical trials have nothing without participants.” Yet, in a 2023 study, 48% of sites cited patient recruitment and enrollment as a top challenge. The downstream impacts of recruitment challenges are profound for sponsors, sites, and most importantly, for patients in need of life-changing therapies. Ironically, on examination, the causes for...
Medical devices are ubiquitous — from thermometers, bandages, and dental floss to blood glucose meters, hearing aids, and complex implantable devices such as pacemakers. The latest cutting-edge examples even extend to apps on tablets and PCs that physicians use to help monitor and treat patients. Before a medical device can be put on the market,...
As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during the development process. The...
All pharmaceutical companies share a common goal, regardless of their size or history: for their products to achieve commercial status and success through the most time- and cost-efficient development path. The 505(b)(2) regulatory pathway was established to offer efficiency benefits for clinical, nonclinical, and chemistry, manufacturing, and controls (CMC) product development. Often sponsors, particularly start-ups...
With drug discovery completed and your lead asset identified, it’s time to initiate IND-enabling activities, moving one step closer to clinical deployment. Because a very small percentage of nonclinical lead assets move into the clinic, your nonclinical program plays a critical role in whether your program advances to Phase 1 and how long it takes to...
CE marking is mandatory for marketing medical devices and in vitro diagnostics (IVDs) in the European single market, comprising all European Union (EU) member states and European Economic Area (EEA) countries. With the introduction of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), there has been a significant overhaul of the...
CE marking is a cornerstone to the functioning of the European single market, which allows free movement of goods among not only the member states of the European Union (EU), but also the countries of the European Economic Area (EEA). For medical devices and in vitro diagnostics (IVDs), CE marking is mandatory for marketing, and...
On September 29, 2023, the U.S. Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. The FDA is proposing a change to its regulations to...